FDA 510(k) Applications Submitted by Rafal Chudzik
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160242 |
02/01/2016 |
Reprocessed Livewire Steerable Diagnostic EP Catheter |
INNOVATIVE HEALTH, LLC |
| K160303 |
02/04/2016 |
Reprocessed Polaris X Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K160421 |
02/16/2016 |
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K160496 |
02/22/2016 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K161393 |
05/19/2016 |
Reprocessed Orbiter ST Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
| K161464 |
05/26/2016 |
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters |
Innovative Health, LLC |
| K153090 |
10/26/2015 |
Reprocessed Diagnostic Ultrasound Catheter |
INNOVATIVE HEALTH, LLC |
| K153153 |
11/02/2015 |
Reprocessed Electrophysiology Catheter |
INNOVATIVE HEALTH, LLC |
| K163560 |
12/19/2016 |
Reprocessed AcuNav Diagnostic Ultrasound Catheter |
Innovative Health, LLC. |
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